(23 days)
The Nichols Advantage Chemiluminescence Tri-Level Specialty Controls is intended for use an assayed quality control serum to monitor the accuracy and precision of the Nichols Advantage immunoassays
Not Found
The provided document is an FDA 510(k) clearance letter for a medical device: "Nichols Advantage Chemiluminescence Tri-Level Specialty Controls." This document primarily grants clearance based on substantial equivalence and does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving those criteria were met.
The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976."
This indicates that the device was deemed substantially equivalent to a predicate device, meaning a comprehensive study with specific acceptance criteria, sample sizes, expert ground truth, and adjudication methods, as typically understood for a new algorithm or AI-based device, is not presented in this document. The focus here is on regulatory clearance based on equivalence rather than detailed performance study results.
Therefore, I cannot provide details for the following questions based on the given text:
- A table of acceptance criteria and the reported device performance: Not available.
- Sample sized used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available (device is a quality control serum, not an AI diagnostic tool).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available (device is a quality control serum, not an algorithm).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 26 1997
Dave D. Smith · Director of Requlatory & Scientific Affairs Nichols Institute Diagnostics ........................ 33608 Ortega Hiqhway San Juan Capistrano, California 92690 Re : K972070 Nichols Advantage Chemiluminescence Tri-Level Specialty Controls Requlatory Class: I
Product Code: JJY Dated: May 30, 1997 Received: June 3, 1997
Dear Mr. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. T Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) Number (if known) K972072
Nichols Advantage Chemiluminescence Device Name:
Tri-Level Specialty Controls
Indications For Use:
The Nichols Advantage Chemiluminescence Tri-Level Specialty Controls is intended for use an assayed quality control serum to monitor the accuracy and precision of the Nichols Advantage immunoassays
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia A. Serolust
Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number
OR
Over-The-Counter Use
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.